The objective of this report is to describe our process and resulting recommendations to CMS for an update to the CED study design requirements. We aimed to refine the study design requirements so that investigators are efficient in completing studies that contribute to an evidence base with the goal of ending the CED process when there is 1) sufficient evidence for a coverage NCD; 2) sufficient evidence for a non-coverage NCD; or 3) a decision to defer the coverage decision to a Medicare Administrative Contractor (MAC). Our goal for the set of requirements is that they will guide investigators to collect and use data generated in the care of patients to produce strong evidence about the health outcomes from use of products by Medicare beneficiaries, with integrity in the scientific process and transparency at all stages.
- Guiding Question 1: What are the strengths and limitations of the current CED criteria (that we now refer to as "requirements")?
- Guiding Question 2: What criteria ("requirements") are used by similar decision-making bodies?
Key Questions (KQ)
- KQ1: What revisions to the CED criteria ("requirements") may best address the limitations while preserving the strengths?
- KQ2: How might the revised criteria ("requirements") be evaluated in the future?